Abstract
A double-blind clinical trial of mitoxantrone versus methylprednisolone was performed in 49 patients with relapsing, secondary multiple sclerosis. Patients were randomized to receive 13 infusions of mitoxantrone 12 mg/m2 (n = 28), or 13 infusions of 1 g of methylprednisolone (n = 21), over 32 months. Twenty-four patients completed the trial. There were no statistical differences between the two groups of patients at study entry. A significant improvement in the Expanded Disability Scale Score (EDSS) was observed in the mitoxantrone group after one year of treatment (p < 0.0022). The total number of relapses, the mean number of relapses/patient/year, and the total number of gadolinium-enhanced lesions on bi-annual MRI scans were significantly decreased in the mitoxantrone group throughout the study period. Nausea, vomiting, and alopecia were more frequent in the mitoxantrone-treated patients. Mitoxantrone has a role in the treatment of MS patients with frequent exacerbations and rapid disease progression.
Publication types
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Clinical Trial
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Alopecia / chemically induced
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Contrast Media
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Double-Blind Method
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Female
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Follow-Up Studies
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Gadolinium
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Humans
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Immunosuppressive Agents / adverse effects
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Immunosuppressive Agents / therapeutic use*
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Lymphocyte Count
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Magnetic Resonance Imaging
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Male
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Methylene Blue / therapeutic use
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Methylprednisolone / adverse effects
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Methylprednisolone / therapeutic use*
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Mitoxantrone / adverse effects
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Mitoxantrone / therapeutic use*
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Multiple Sclerosis / drug therapy*
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Multiple Sclerosis / pathology
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Nausea / chemically induced
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Nausea / prevention & control
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Patient Dropouts
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Phlebitis / chemically induced
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Phlebitis / complications
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Pulmonary Embolism / etiology
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Pyrrolidines / therapeutic use
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Recurrence
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Severity of Illness Index
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Treatment Outcome
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Vomiting / chemically induced
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Vomiting / prevention & control
Substances
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Contrast Media
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Immunosuppressive Agents
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Pyrrolidines
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Gadolinium
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Mitoxantrone
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alizapride
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Methylene Blue
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Methylprednisolone